Director, Biostatistics

CSL

Director Biostatistics leading statistical contributions to clinical development plans and regulatory submissions. Collaborating with stakeholders and ensuring successful data package delivery.

Posted 4/23/2026full-timeWaltham • Massachusetts, Pennsylvania • 🇺🇸 United StatesLeadWebsite

About the role

Key responsibilities & impact

Define the statistical strategy and ensure appropriate statistical methodologies applied to the clinical development plan, study design and data analysis for clinical trials, and regulatory submissions.
Provide statistical insight into execution of clinical development, to ensure study conduct leads to a statistically sound and robust data package, maximize probability of program success.
Interprets analysis results and ensures reporting accuracy in study reports and regulatory documents, abstracts, posters, oral presentations, manuscripts and written reports to effectively communicate results of clinical programs and studies.
May serve as the point of contact for one or more PSTs within the Therapeutic Area.
Lead or provide oversight to the analysis delivery and quantitative evaluation of clinical trials, and integrated analysis.
Represent Biostatistics in interactions with regulatory authorities (eg, FDA, EMA, PMDA), which includes leading written responses to regulatory questions and attending regulatory meetings.

Requirements

What you’ll need

PhD or MS/MA in statistics or related field
10+ years of experience in clinical development within the pharmaceutical or biotechnology industry
Demonstrated leadership in statistical contributions to clinical programs and regulatory submissions
Experience partnering with cross-functional teams and interacting with health authorities
Experience managing external partners (CROs, consultants)
Strong statistical methodology knowledge and clinical trial design expertise
Ability to collaborate and influence across functions and levels
Excellent communication and interpersonal skills
Experience with CDISC standards, programming oversight, and statistical operations
Strategic and analytical mindset with a focus on execution
Ability to work in a matrixed environment and lead through influence

Benefits

Comp & perks

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL

ATS Keywords

✓ Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

statistical methodologiesclinical trial designdata analysisstatistical insightprogram success probabilityanalysis deliveryquantitative evaluationCDISC standardsprogramming oversightstatistical operations

Soft Skills

leadershipcollaborationinfluencecommunicationinterpersonal skillsstrategic mindsetanalytical mindsetexecution focuscross-functional teamworkmatrixed environment adaptability

Certifications

PhD in statisticsMS/MA in statistics or related field